Cleared Traditional

K171518 - Epidural Anesthesia Needles

K171518 is an FDA 510(k) clearance for Epidural Anesthesia Needles, manufactured by Zhejiang Kindly Medical Devices Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K171518 · Zhejiang Kindly Medical Devices Co., Ltd. · Anesthesiology device
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Jan 2018
Decision
226d
Days
Class 2
Risk

K171518 is an FDA 510(k) clearance for the Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia N.... Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Zhejiang Kindly Medical Devices Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on January 5, 2018 after a review of 226 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhejiang Kindly Medical Devices Co., Ltd. devices

FDA 510(k) Submission Details - K171518

510(k) Number K171518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2017
Decision Date January 05, 2018
Days to Decision 226 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 140d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSP Device Classification - Class 2, Special Controls

Product Code BSP Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 72
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K171518.
StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle
K173321 · Teleflex Medical · Apr 2018
IMD's Lumbar Puncture Needle
K170112 · International Medical Development, Inc.(Imd) · Feb 2018
EchoGlo Needle
K171968 · Smiths Medical Asd, Inc. · Jan 2018
NerveGuard NRFit, NerveGuard LUER
K170435 · PAJUNK GmbH Medizintechnologie · Jul 2017
Pinpoint GT Needles
K163216 · C.R. Bard, Inc. · Jun 2017
Entellus Medical Reinforced Anesthesia Needle
K163435 · Entellus Medical, Inc. · Apr 2017